Introduction to the FDA
21 CFR Part 11/Annex 11 - Compliance for Electronic Records and Signatures
The Five Keys to COTS Computer System Validation
Ten-Step Process for COTS Risk-Based Computer System Validation
How to Write Requirements and Specifications
How to Conduct a Hazard Analysis/Risk Assessment-Exercise
Software Testing
System Change Control
Purchasing COTS Software
Cost Reduction Without Increasing Regulatory or Business Risk
You can register for this seminar paying either by cheque or Demand Draft. To register, please make out your cheque or Demand Draft for the prescribed amount and send it to the address given below:
NetZealous Services India Pvt. Ltd.
Gururaya Mansion, 759 to 764, 8th Main road, J.P.Nagar,
Bangalore - 560078 Karnataka, INDIA
Computer System Validation's principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. He has completed more than 260 mission critical laboratory, clinical, and manufacturing software implementation projects. His most popular book is Risk Based Software Validation - Ten easy Steps, which provides fill-in-the-blank templates for completing a COTS software validation project.
Services are available to guide companies to create and maintain the systems and procedures required to pass regulatory inspections: product features, vendor audits, software validation, SOPs, training, gap analysis, remediation plans, and project management.
Projects involve: medical devices, blood bank, clinical trial, corrective action, document control, electronic data capture, Excel spreadsheets, laboratory instruments, laboratory information management (LIMS), manufacturing, enterprise resource planning, toxicology systems, and VMWare.
David Nettleton is also the co-author of:
Mahatma Gandhi once lived in this simple, two-story building, which is now a museum, library and research center depicting Gandhi's life and struggles for Indian freedom through peaceful means.
This is a bridge which links Mumbai's suburbs to South Mumbai. It's a very prestigious bridge which was opened in 2009.
Landmarks/ Points of Interest; Scenic Drives Bordering the Arabian Sea, this famous road is a popular spot for watching sunsets, and is gorgeous when lit up at night.
The Gateway of India is of course, the logical place from where to begin your tour of Mumbai. After all, you're following in the footsteps of royalty! The English King George V landed in India in 1911 at this very spot, and the citizens of Bombay pooled money and ideas to build this grand memorial to him.
The action starts at night at this famous beach, which is lined with vendors, entertainers, children's rides and fast food stalls selling bhelpuris (puffed rice snacks) and other Indian delights.
India's most beautiful railway station is a masterpiece of Gothic architecture with stained-glass windows, towering spires, domed arches and buttresses and pillars with animal images carved into them.
NetZealous Services India Pvt. Ltd.
Gururaya Mansion, 759 to 764, 8th Main road, J.P.Nagar,
Bangalore - 560078
Karnataka,INDIA.
Call: 080-68439500